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Design, methodology, and baseline data of the Personalized Addition Lenses Clinical Trial (PACT).

Abstract The aim of this study was to describe the design, methods, and baseline characteristics of children enrolled in the Personalized Addition lenses Clinical Trial (PACT). PACT aims to test the myopia control efficacy of progressive addition lenses (PALs) with personalized addition values compared with standard (+2.00 D) addition PALs and single vision lenses (SVLs).
PMID
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Authors

Mayor MeshTerms

Eyeglasses

Keywords
Journal Title medicine
Publication Year Start




PMID- 28296722
OWN - NLM
STAT- MEDLINE
DA  - 20170315
DCOM- 20170324
LR  - 20170403
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Linking)
VI  - 96
IP  - 11
DP  - 2017 Mar
TI  - Design, methodology, and baseline data of the Personalized Addition Lenses
      Clinical Trial (PACT).
PG  - e6069
LID - 10.1097/MD.0000000000006069 [doi]
AB  - BACKGROUND: The aim of this study was to describe the design, methods, and
      baseline characteristics of children enrolled in the Personalized Addition lenses
      Clinical Trial (PACT). PACT aims to test the myopia control efficacy of
      progressive addition lenses (PALs) with personalized addition values compared
      with standard (+2.00 D) addition PALs and single vision lenses (SVLs). METHODS:
      PACT is a randomized, controlled, double-masked clinical trial. Two hundred
      eleven myopic Chinese children (7-12 years) were enrolled and randomized into 1
      of the 3 following groups: personalized addition PALs; +2.00 addition PALs; and
      SVLs. Personalized addition values were determined based on the highest addition 
      that satisfied Sheard criterion. Axial length and other biometric data were also 
      recorded. RESULTS: At baseline, no differences were found between the right and
      left eyes for any of the main parameters. The enrolled children were 9.7 +/- 1.1 
      years' old with cycloplegic autorefraction (right eye [OD]: -2.36 +/- 0.64 D),
      near phoria (1.0 +/- 5.0 prism diopter esophoria), lag of accommodation (1.40 +/-
      0.50 D) and axial length (OD: 24.58 +/- 0.74 mm). The personalized addition
      values ranged from +0.75 to +3.00 (average +/- SD: 2.19 +/- 0.73 D). CONCLUSION: 
      PACT is a clinical trial evaluating whether myopia progression in children can be
      slowed by wearing personalized addition PALs compared with fixed addition PALs
      and SVLs as measured by cycloplegic autorefraction and axial length. Baseline
      data were comparable with those of previous myopia control studies in children.
      Subjects will be followed up every 6 months for 2 years.
FAU - Yu, Xinping
AU  - Yu X
AD  - aThe Eye Hospital of Wenzhou Medical University bWMU-Essilor international
      Research Centre cR&D Asia, Essilor International, Wenzhou, Zhejiang, China.
FAU - Zhang, Binjun
AU  - Zhang B
FAU - Bao, Jinhua
AU  - Bao J
FAU - Zhang, Junxiao
AU  - Zhang J
FAU - Wu, Ge
AU  - Wu G
FAU - Xu, Jinling
AU  - Xu J
FAU - Zheng, Jingwei
AU  - Zheng J
FAU - Drobe, Bjorn
AU  - Drobe B
FAU - Chen, Hao
AU  - Chen H
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
SB  - AIM
SB  - IM
MH  - Child
MH  - Disease Progression
MH  - Double-Blind Method
MH  - *Eyeglasses
MH  - Humans
MH  - Myopia/*therapy
MH  - Research Design
PMC - PMC5369877
EDAT- 2017/03/16 06:00
MHDA- 2017/03/25 06:00
CRDT- 2017/03/16 06:00
AID - 10.1097/MD.0000000000006069 [doi]
AID - 00005792-201703170-00003 [pii]
PST - ppublish
SO  - Medicine (Baltimore). 2017 Mar;96(11):e6069. doi: 10.1097/MD.0000000000006069.

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